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FDA (Device enforcement)Recalled 2023-11-21class ii

Exactech, Inc.: Exactech Novation Hip System, Catalog Numbers: 134-36-45

Hazard

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Details from the source

Reason for recall: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Distribution: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK Quantity: N/A Lot/code info: GTIN 10885862024046, Serial Numbers: A763009, A763010, A763011, A763017, A763018, A763020

UPC codes

10885862024046

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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